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Senior Regulatory Affairs Specialist

Remote / Hybrid

South Wales

23191/617

£40,000 - £55,000 and further benefits

What is on offer?

• A salary of up to £55,000
• Remote working (Occasional travel to site depending on location)
• 25 days holidays plus bank holidays
• Pension Scheme
• Healthcare cash plan
• Sick Pay
• Life Assurance

An award-winning medical manufacturer in South West Wales is currently looking to strengthen its Regulatory team with the key acquisition of a Senior Regulatory Affairs Specialist. With investment secured for the next 5 years, this company is in a leading position to capitalise on the market. They are targeting significant growth this year after releasing a new product into market.

Senior Regulatory Affairs Specialist Role:

• Monitor changes in global regulatory requirements and communicate their impact to the organisation.
• Develop and execute regulatory strategies for new and existing medical devices.
• Collaborate with cross-functional teams to ensure timely submission of documents and approvals.
• Maintaining and updating product technical files
• Prepare, review, and submit regulatory documents to health authorities, including 510(k), PMA, CE Mark, and international submissions.
• Work with cross-functional teams to resolve compliance issues and deviations. Collaborate with the Quality Assurance team to ensure that the quality system aligns with regulatory requirements (ISO 13485, FDA QSR, etc.).
• Coordinate and participate/host internal and external audits to assess compliance with regulatory standards.

What you need?

• Bachelor's degree in a relevant field (e.g., life sciences, engineering, regulatory affairs). Master's degree is a plus.
• Ideally 4 -5 years of experience in regulatory affairs in the medical devices industry.
• Strong knowledge of global medical device regulations, including UKCA, CE marking, and regional requirements in ASPAC and LATAM markets.